Medtronic, which develops, manufactures and sells medical remedy units, has issued a voluntary recall of its MiniMed 600 sequence or 700 sequence insulin pumps as a result of pump’s doubtlessly shortened battery life.
The corporate issued a area motion, beginning on July 31, notifying prospects globally that they need to monitor their MiniMed pump’s built-in alarms and alerts to maintain observe of battery standing and make contact with the corporate in the event that they discover adjustments within the pump’s battery life.
Medtronic mentioned it started analyzing its pump’s battery life after receiving buyer complaints that if the pump was bumped, dropped or had any bodily impression even as soon as, they skilled a shortened battery life both instantly after the drop or over time as a consequence of harm to the system’s inner electrical parts.
“This electrical situation additionally causes battery alerts to happen when much less battery life stays than the Consumer Information states. This may increasingly consequence within the pump stopping insulin supply considerably earlier than normally anticipated and will result in well being dangers like hyperglycemia or diabetic ketoacidosis (DKA), doubtlessly requiring medical intervention,” the corporate mentioned in an announcement.
“Most not too long ago, Medtronic has acquired 170 stories of hyperglycemia >400 mg/dL and 11 stories of diabetic ketoacidosis from January 2023 to September 2024 within the U.S. doubtlessly associated to this situation.”
The FDA labeled the problem as a category I recall, which is probably the most severe sort of recall, which means there’s a affordable probability that utilizing the product might end in severe harm or dying.
The corporate mentioned the pump would nonetheless generate battery alerts and alarms, however they might not be delivered “with the same old quantity of battery life remaining earlier than the battery have to be changed to keep away from the pump stopping insulin supply.”
Medtronic mentioned customers ought to change the battery as quickly because the “Low Battery Pump” alarm sounds, carry an additional set of batteries ought to they have to be changed earlier than anticipated, and have a backup remedy in case it’s wanted.
The Dublin-based firm mentioned no matter whether or not the pump has skilled a drop or one other bodily impression, customers who expertise a major lower in battery life ought to contact the corporate to find out if a substitute pump is required.
